Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
Cargus International, Inc.
ORAL
OTC DRUG
Oral Anesthetic For the temporary relief of pain associated with canker sores and minor dental procedures.
OTC monograph not final
MARK 3- BENZOCAINE GEL CARGUS INTERNATIONAL, INC. _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- ACTIVE INGREDIENT Benzocaine, 20% PURPOSE Oral Anesthetic USES For the temporary relief of pain associated with canker sores and minor dental procedures. WARNINGS ALLERGY ALERT Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics. DO NOT use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly DO NOT exceed recommended dosage. KEEP OUT OF REACH OF CHILDREN. IF MORE THAN USED FOR PAIN IS ACCIDENTIALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. DIRECTIONS Adults and children 12 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor Children under 12 years of age should be supervised in the use of the product. Children under 2 years of age: Consult a dentist or doctor. OTHER INFORMATION Store at room temperature 59 - 86°F (15 - 30°C). Protect from freezing and heat. INACTIVE INGREDIENTS FD&C Red No. 40, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol DISTRIBUTED BY Mark 3, 135 North Rt. 9W, Congers, NY 10920 1.888.732.2913 Mark 3 Oral Anesthetic Gel Cherry Gluten Free with Vitamin E and Xylitol NDC 61509-101-32 Net Wt. 1.12 oz. (32 g) Distributed by Mark 3, 135 North Rt. 9W, Congers, NY 10920 Made in USA MARK 3 benzocaine gel PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:61509-101 ROUTE OF ADMINISTRATION ORAL, DENTAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENG Belgenin tamamını okuyun